05
Safety

Could there be as yet unidentified side effects of the vaccines?

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12/9/2021

After the successful completion of phase III trials and after the product is licensed, phase IV studies, also called post-marketing surveillance studies, are used to continue monitoring the safety and effectiveness of the vaccine once applied to the population. Phase IV constitutes the expansion of knowledge about the efficacy of the vaccine once it has been approved for commercialization and begins to be applied systematically in the population. In addition to the adverse reactions that could occur with its use and that had not been detected in the previous phases, the effectiveness is also evaluated through continuous epidemiological surveillance.

Some previously unidentified side effects could be detected when the number of vaccinees and the heterogenicity of the population is increased, however, these should be very rare and safety monitoring programmes are in place to monitor and evaluate them.

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